EUCTR2014-000936-40-DE进行中（未招募）1 期
pilot study to investigate the effect of e.-coli-nissle as probiotic adjuvant to antidiabetic standard care in patients with diabetic mellitus type 2 - PUNiDIA
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- GWT-TUD GmbH
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Diabetes mellitus type 2
- •- HbA1c >7% (stable for 6 months)
- •- oral antidiabetic therapie for 6 months with Metformin, Vildagliptin, Gliniden or without Oral antidiabetic medication
- •- age between 45 and 80 years
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 5
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •-Myocardial infarction or stroke within the last 5 years
- •- insulin therapy
- •-Therapy with arcabose
- •-Acute periphere arterial disease within the last 12 months
- •-Insable metabolic situation
- •-Uncontrolled hypertension
- •-Body-Mass-Index = 35 kg/m²
- •-Daily consumption of probiotic food
- •-Malignant disease within the last 5 years
- •-Status post transplantation
- •-Immunosuppressive therapy within the last 3 months
- •-Therapy with antibiotics
- •-Macroalbuminuria
- •-Severe liver disease
研究者
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